Defining REMS Success An Unanswered Question For Daiichi's Pexidartinib
US FDA still deliberating on how best to measure success of the liver safety program for Daiichi's TGCT treatment, but REMS will probably assess both process and outcomes.
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Daiichi Must Follow Turalio Patients For 10 Years To Assess Liver Safety
As the US FDA suggested during its advisory committee review, a long-term safety study is among the postmarketing commitments for the tenosynovial giant cell tumor treatment.
Multiple Firsts As Pexidartinib Approved In US - With Warning
Further progress for Daiichi Sankyo's strategic push into oncology as US issues first approval globally for first-in-class rare disease drug Turalio - but with liver toxicity safeguards.
Daiichi’s Quizartinib And The Quintessential 'Pazdur Moment'
Daiichi Sankyo made a strong case to rebut US FDA’s concerns about the 'credibility' of a survival benefit reported for its refractory AML therapy quizartinib in front of the Oncologic Drugs Advisory Committee. Then Richard Pazdur spoke.